Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02518178
Status:
UNKNOWN
Last Update Posted:
2015-08-07
First Post:
2015-08-01
Brief Title:
Khushi Baby KB Novel Mobile Health Solution for Vaccination Record Keeping in India
Sponsor:
Khushi Baby Inc
Organization:
Khushi Baby Inc
Study Overview
Official Title:
Khushi Baby KB Efficacy and Impact Assessment of Novel Mobile Health Solution for Vaccination Record Keeping in Rural Udaipur Rajasthan India
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a three arm cluster randomized controlled trial where the unit of randomization is the immunization camp Immunization camps are the sole provider of vaccinations in our study area and have catchment areas of several villages The 96 immunization camps will be randomized evenly to one of three arms
1 control arm where near field communication NFC stickers will be placed on existing immunization booklets These stickers can be scanned using a mobile phone with an installed application whereby information can be entered onto the phone and then scanned onto the sticker
2 pendant only where the same NFC technology will be placed into a pendant that is worn by the infant and
3 pendant as described above with voice reminders sent 15 days 1 day prior and the day of the scheduled immunization camp dates
1 control arm where near field communication NFC stickers will be placed on existing immunization booklets These stickers can be scanned using a mobile phone with an installed application whereby information can be entered onto the phone and then scanned onto the sticker
2 pendant only where the same NFC technology will be placed into a pendant that is worn by the infant and
3 pendant as described above with voice reminders sent 15 days 1 day prior and the day of the scheduled immunization camp dates
Detailed Description:
Routine immunization RI is an important tool to achieve the UN Millennium Development Goal MDG 4 of reducing child mortality by ensuring childhood protection from infectious disease Recent 2013 estimates found that of approximately 63 million children died before their fifth birthday with 518 33 million of these deaths attributed to infectious diseases Liu et al 2014 In regards to vaccine preventable diseases VPDs pneumonia 935000 deaths and diarrhea 578000 deaths were responsible for the most deaths Measles pertussis tetanus and meningitis four other vaccine preventable diseases were responsible for 362000 deaths in children under five years old Liu et al 2014
Vaccination is one of the most cost-effective interventions for increasing childhood survival WHO 2009 Global estimates find that current immunization programs save over 25 million lives a year WHO 2009 Despite the lifesaving potential of vaccines in 2012 approximately 17 of children or about 23 million infants did not receive all the scheduled vaccines CDC 2013 and if they were immunized they often received the vaccinations late Clark Sanderson 2009
In 1985 the Government of India launched the Universal Immunization Programme UIP to protect all infants 0-12 months against six preventable diseases tuberculosis diphtheria pertussis tetanus poliomyelitis and measles The goal of UIP was to ensure 100 coverage of all eligible children with one dose of BCG three doses of DTP and OPV and one dose of the measles vaccine According to the Coverage Evaluation Survey CES 2009 a nationwide survey covering all States and Union Territories of India conducted during November 2009 to January 2010 by UNICEF the national fully immunized coverage FIC against the six vaccines included in UIP in the age-group of 12-23 month old children was just 61 CES 2009 Coverage with third dose of diphtheria tetanus and pertussis vaccine DTP3 is a widely accepted global indicator for RI program performance Lim SS et al 2008 India national estimates found DTP3 coverage was 72 WHO India 2011 against a global target of 90 The District Level Health Survey 3 DLHS 3 findings suggest that the retention rate of childhood immunization was in maximum decline between the second round of DT and polio - 70 and the third round - 56 Shekhar Yadav 2013
The proposed study site the Udaipur district of Rajasthan has traditionally had lower immunization estimates than national levels while also performing poorly in other key developmental indicators infant mortality rate IMR is 47 per 1000 live births SRS Bulletin 2014 GoI and maternal mortality rate MMR is 244 per 100000 women of reproductive age MMR Bulletin 2013
To counter the long-standing deficiencies in immunization coverage and other health outcomes a non-governmental organization NGO named Seva Mandir began operations in the area starting in 2004 Seva Mandir has had a long standing relationship with over 700 villages in Rajasthan with 105 villages participating in their immunization program Immunization camps take place at regular expected intervals throughout the month so caregivers are aware of when the scheduled camps will take place This study area and its partners have conducted a seminal randomized controlled trial on non-monetary incentives to improve immunization coverage Banerjee A et al 2010
Although there has been a renewed global focus on improving immunization coverage levels Alonso PL et al 2013 Berkley S et al 2013 Rajasthan district still performs poorly in routine immunization delivery and reporting In efforts to improve the delivery and reporting of immunizations with subsequent gains in proportions of infants fully vaccinated we will conduct a cluster RCT that employs novel mHealth technologies to improve the reporting of immunization records and to increase the demand for immunizations through the use of voice message reminders
One of these novel mHealth technologies is the use of a wearable electronic immunization record This technology couples a mobile application app for health workers with a wearable digital pendant necklace for individuals that store their updated medical history The pendant contains a readwritable NFC chip which allows health workers to digitally update a participants vaccination records with the tap of a phone and without the need to be connected to a central database This technology can also be placed into a sticker that could be attached to an immunization booklet which would simplify record keeping Importantly this technology can be distinguished from other mHealth solutions as it does not require a centralized database of patients to look up patient specific records Rather the solution is decentralized allowing patients to wear their vaccine history on a necklace that can be accessed digitally in the last mile at the point of care This work extends the use NFC trackers to simply identify patients and count disease occurrence Marcus et al 2009 to medical record storage at the point of care The potential for the necklace to play a symbolic role for the promotion of health benefits is an additional reason for the chosen form factor
The pendant with NFC technology was developed by students at Yale as part of a class project and is called Khushi Baby KB Yale investigators visited the proposed study site to informally solicit local opinions on the proposed pendant and to receive feedback from Seva Mandir immunization teams to make the KB app user friendly Importantly this pendant is contextually relevant as many children in this study area wear similar talismans with the local thought being that they promote good health and can prevent coughs
Others have found that the color and shape of insecticide bed nets was a relevant factor in influencing peoples willingness-to-buy the ITNs and thereby adopt the intervention in Southern Ethiopia Gebresilassie Mariam 2011 The KB necklace a unique feature of the system also merits a deeper investigation into the characteristics that influence its adoption and whether it can generate a peer effect throughout the community which impacts vaccination adherence rates
In addition to potentially being able to increase demand for vaccination the NFC chip pendant could potentially improve the quantity and quality of immunization services available through a more efficient monitoring and outreach system The current paper system is prone to loss of records due to wear and tear over the 9 to 12 month process to complete immunizations Paper systems also have the disadvantages of being difficult to query not individually specific as data is aggregated and transferred and out-dated due to the time lag in data entry The system to digitize vaccine records makes individually specific data available to remote monitors in real time so that they can better manage vaccine stock resource mobilization for camps and camp reminder messages via automated voice reminders to childs household mobile phones It also holds promise in improving workflow in the field Simply scanning the chip quickly brings a childs records and their due vaccines for the visit without guesswork based on otherwise incomplete records Finally new information such as events of vaccine denial and reasons for vaccine denials can be automatically recorded to reveal greater insights on the true vaccine demand for a given village
Data do not only have the potential to inform the service delivery NGO but in this system to also connect back with the community being served via voice call reminders Many mHealth pilots on push based reminders systems have shown promise in improving health outcomes in developing countries eg MedicMobile M-Power Frontline SMS Mobile Alliance for Maternal Action however further evidence must be collected to determine whether personalized voice calls can specifically reduce immunization drop out An automated backend allows our push system to reach mothersprimary caregivers in villages before their baby is due for hisher next vaccine
Our approach stands to be successful for several reasons
mHealth solutions have been successfully used to improve the quality and efficiency of data collection across a range of health outcomes even in developing world settings
SMS reminders have shown some success to improve immunization coverage and timeliness in other developing areas Bangure et al 2015 we look to seek enhancement of this effect through personalized voice reminders in local language
Mobile phone ownership and access levels are at an all-time global high Globally the number of people owning mobile phones grew from 1 billion in 2000 to 6 billion in 2012 World Bank 2012 Reaching the last mile may be facilitated through remote reminder systems that alleviate the burden of local workers hired to go door-to-door walking tens of miles the day before an immunization camp
Monthly immunization camps are the predominant avenue for infants to be vaccinated This immunization delivery system benefits the proposed study as study staff will not have to travel to many different clinics andor households to track enrolled infants immunization status
Vaccination is one of the most cost-effective interventions for increasing childhood survival WHO 2009 Global estimates find that current immunization programs save over 25 million lives a year WHO 2009 Despite the lifesaving potential of vaccines in 2012 approximately 17 of children or about 23 million infants did not receive all the scheduled vaccines CDC 2013 and if they were immunized they often received the vaccinations late Clark Sanderson 2009
In 1985 the Government of India launched the Universal Immunization Programme UIP to protect all infants 0-12 months against six preventable diseases tuberculosis diphtheria pertussis tetanus poliomyelitis and measles The goal of UIP was to ensure 100 coverage of all eligible children with one dose of BCG three doses of DTP and OPV and one dose of the measles vaccine According to the Coverage Evaluation Survey CES 2009 a nationwide survey covering all States and Union Territories of India conducted during November 2009 to January 2010 by UNICEF the national fully immunized coverage FIC against the six vaccines included in UIP in the age-group of 12-23 month old children was just 61 CES 2009 Coverage with third dose of diphtheria tetanus and pertussis vaccine DTP3 is a widely accepted global indicator for RI program performance Lim SS et al 2008 India national estimates found DTP3 coverage was 72 WHO India 2011 against a global target of 90 The District Level Health Survey 3 DLHS 3 findings suggest that the retention rate of childhood immunization was in maximum decline between the second round of DT and polio - 70 and the third round - 56 Shekhar Yadav 2013
The proposed study site the Udaipur district of Rajasthan has traditionally had lower immunization estimates than national levels while also performing poorly in other key developmental indicators infant mortality rate IMR is 47 per 1000 live births SRS Bulletin 2014 GoI and maternal mortality rate MMR is 244 per 100000 women of reproductive age MMR Bulletin 2013
To counter the long-standing deficiencies in immunization coverage and other health outcomes a non-governmental organization NGO named Seva Mandir began operations in the area starting in 2004 Seva Mandir has had a long standing relationship with over 700 villages in Rajasthan with 105 villages participating in their immunization program Immunization camps take place at regular expected intervals throughout the month so caregivers are aware of when the scheduled camps will take place This study area and its partners have conducted a seminal randomized controlled trial on non-monetary incentives to improve immunization coverage Banerjee A et al 2010
Although there has been a renewed global focus on improving immunization coverage levels Alonso PL et al 2013 Berkley S et al 2013 Rajasthan district still performs poorly in routine immunization delivery and reporting In efforts to improve the delivery and reporting of immunizations with subsequent gains in proportions of infants fully vaccinated we will conduct a cluster RCT that employs novel mHealth technologies to improve the reporting of immunization records and to increase the demand for immunizations through the use of voice message reminders
One of these novel mHealth technologies is the use of a wearable electronic immunization record This technology couples a mobile application app for health workers with a wearable digital pendant necklace for individuals that store their updated medical history The pendant contains a readwritable NFC chip which allows health workers to digitally update a participants vaccination records with the tap of a phone and without the need to be connected to a central database This technology can also be placed into a sticker that could be attached to an immunization booklet which would simplify record keeping Importantly this technology can be distinguished from other mHealth solutions as it does not require a centralized database of patients to look up patient specific records Rather the solution is decentralized allowing patients to wear their vaccine history on a necklace that can be accessed digitally in the last mile at the point of care This work extends the use NFC trackers to simply identify patients and count disease occurrence Marcus et al 2009 to medical record storage at the point of care The potential for the necklace to play a symbolic role for the promotion of health benefits is an additional reason for the chosen form factor
The pendant with NFC technology was developed by students at Yale as part of a class project and is called Khushi Baby KB Yale investigators visited the proposed study site to informally solicit local opinions on the proposed pendant and to receive feedback from Seva Mandir immunization teams to make the KB app user friendly Importantly this pendant is contextually relevant as many children in this study area wear similar talismans with the local thought being that they promote good health and can prevent coughs
Others have found that the color and shape of insecticide bed nets was a relevant factor in influencing peoples willingness-to-buy the ITNs and thereby adopt the intervention in Southern Ethiopia Gebresilassie Mariam 2011 The KB necklace a unique feature of the system also merits a deeper investigation into the characteristics that influence its adoption and whether it can generate a peer effect throughout the community which impacts vaccination adherence rates
In addition to potentially being able to increase demand for vaccination the NFC chip pendant could potentially improve the quantity and quality of immunization services available through a more efficient monitoring and outreach system The current paper system is prone to loss of records due to wear and tear over the 9 to 12 month process to complete immunizations Paper systems also have the disadvantages of being difficult to query not individually specific as data is aggregated and transferred and out-dated due to the time lag in data entry The system to digitize vaccine records makes individually specific data available to remote monitors in real time so that they can better manage vaccine stock resource mobilization for camps and camp reminder messages via automated voice reminders to childs household mobile phones It also holds promise in improving workflow in the field Simply scanning the chip quickly brings a childs records and their due vaccines for the visit without guesswork based on otherwise incomplete records Finally new information such as events of vaccine denial and reasons for vaccine denials can be automatically recorded to reveal greater insights on the true vaccine demand for a given village
Data do not only have the potential to inform the service delivery NGO but in this system to also connect back with the community being served via voice call reminders Many mHealth pilots on push based reminders systems have shown promise in improving health outcomes in developing countries eg MedicMobile M-Power Frontline SMS Mobile Alliance for Maternal Action however further evidence must be collected to determine whether personalized voice calls can specifically reduce immunization drop out An automated backend allows our push system to reach mothersprimary caregivers in villages before their baby is due for hisher next vaccine
Our approach stands to be successful for several reasons
mHealth solutions have been successfully used to improve the quality and efficiency of data collection across a range of health outcomes even in developing world settings
SMS reminders have shown some success to improve immunization coverage and timeliness in other developing areas Bangure et al 2015 we look to seek enhancement of this effect through personalized voice reminders in local language
Mobile phone ownership and access levels are at an all-time global high Globally the number of people owning mobile phones grew from 1 billion in 2000 to 6 billion in 2012 World Bank 2012 Reaching the last mile may be facilitated through remote reminder systems that alleviate the burden of local workers hired to go door-to-door walking tens of miles the day before an immunization camp
Monthly immunization camps are the predominant avenue for infants to be vaccinated This immunization delivery system benefits the proposed study as study staff will not have to travel to many different clinics andor households to track enrolled infants immunization status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None